Adjuvant Therapy for High-Risk Intrahepatic Cholangiocarcinoma: A Real-World Study

June 5, 2026 updated by: Shunda Du, Peking Union Medical College Hospital

A Real-World Study on Postoperative Adjuvant Therapy for Intrahepatic Cholangiocarcinoma Patients With High-Risk Recurrence Factors

This multicenter real-world study assesses the efficacy and safety of adjuvant therapies in postoperative intrahepatic cholangiocarcinoma (ICC) patients with high-risk recurrence factors.

90 eligible patients will be assigned to: Cohort 1: GP (gemcitabine/cisplatin) + adebrelimab Cohort 2: Apatinib + adebrelimab Cohort 3: S-1 (tegafur/gimeracil/oteracil) + adebrelimab Outcomes will be compared against historical real-world controls receiving standard chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Baoluhe Zhang
  • Phone Number: 010-69152831
  • Email: dushd@pumch.cn

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking Union Medical College Hospital (PUMCH)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with intrahepatic cholangiocarcinoma (ICC) at high risk of recurrence

Description

Inclusion Criteria:

  • Histologically confirmed ICC within 12 weeks after curative resection
  • Any T stage; N0/N+; M0.
  • At least one high-risk factor:

Preoperative tumor penetration of the liver capsule or extrahepatic direct invasion; Preoperative imaging showing multifocal lesions or a single lesion >5 cm; Vascular invasion (preoperative or postoperative pathology); Regional lymph node metastasis.

  • No prior systemic therapy for ICC.
  • ECOG performance status 0-2.
  • Expected survival ≥3 months.
  • Adequate organ function.
  • Agreement to use effective contraception (or surgical sterilization) during the study and for 120 days after the last dose.
  • Signed informed consent and anticipated good compliance with the study protocol.

Exclusion Criteria:

  • Immunosuppressive therapy within 28 days prior to enrollment (excluding topical/inhaled corticosteroids or physiologic steroid doses ≤10 mg/day prednisone equivalent).
  • Systemic anticancer herbs/immunomodulators (e.g., thymosin, interferons) within 4 weeks, except for pleural effusion control.
  • Uncontrolled cardiovascular disease:

Unstable angina/myocardial infarction Arrhythmias with QTc ≥450 ms (men) or ≥470 ms (women) NYHA Class III-IV heart failure or LVEF <50%

  • Active infections (IV antibiotics/antivirals required) or fever >38.5°C within 4 weeks; or major surgery within 3 weeks.
  • Active autoimmune/immunodeficiency diseases (e.g., hepatitis, pneumonitis, rheumatoid arthritis), except:

Hypothyroidism on stable hormone replacement Type 1 diabetes with controlled glucose Uncontrolled asthma requiring systemic bronchodilators (resolved childhood asthma allowed).

- Active infections: HIV/AIDS

HBV (DNA ≥500 IU/mL) or HCV (RNA-positive) unless:

HBV DNA <500 IU/mL + antiviral therapy ≥14 days

  • Prior/proposed organ transplantation (excluding corneal grafts).
  • Concurrent interventional trials or investigational drugs within 4 weeks without recovery to Grade ≤1 toxicity.
  • Hypersensitivity to study drug components.
  • Allogeneic transplant history/plans.
  • Uncontrolled psychiatric/substance abuse disorders.
  • Refractory hypertension (≥140/90 mmHg despite treatment).
  • Clinically significant bleeding/thromboembolism:

GI bleeding within 3 months Thrombotic events within 6 months (stroke, DVT/PE)

  • Coagulopathy (INR >1.5, PT >ULN+4s, aPTT >1.5×ULN) or anticoagulant use.
  • Proteinuria ≥++ on dipstick or 24-h urine protein ≥1 g.
  • Other high-risk conditions per investigator judgment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cohort 1: GP + adebrelimab
Drug: Adebrelimab
Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
Drug: Gemcitabine
Gemcitabine administered intravenously at [1000 mg/m^2] on days 1 and 8 of each [21]-day cycle, for up to 8 cycles, in combination with cisplatin and adebrelimab，
Drug: Cisplatin
Cisplatin administered intravenously at [25 mg/m^2] on days 1 and 8 of each [21]-day cycle, for up to 8 cycles, in combination with gemcitabine and adebrelimab.
Cohort 2: Apatinib + adebrelimab
Drug: Adebrelimab
Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
Drug: Apatinib
Apatinib administered orally at [250mg] once daily continuously, for up to 17 cycles, in combination with adebrelimab.
Cohort 3: S-1 + adebrelimab
Drug: Adebrelimab
Adebrelimab administered intravenously at [1200mg] on day 1 of each 21-day cycle, for up to 17 cycles, common to all three cohorts.
Drug: S-1
S-1 (tegafur/gimeracil/oteracil) administered orally twice daily on days 1-14 of each 21-day cycle, dosed according to body surface area, for up to 8 cycles, in combination with adebrelimab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence-Free Survival (RFS)
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: Through study completion, an average of 4 years
Through study completion, an average of 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Principal Investigator: Shunda Du, Peking Union Medical College Hospital (PUMCH)
  • Principal Investigator: Mei Guan, Peking Union Medical College Hospital (PUMCH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 26, 2025

First Submitted That Met QC Criteria

June 5, 2026

First Posted (Actual)

June 10, 2026

Study Record Updates

Last Update Posted (Actual)

June 10, 2026

Last Update Submitted That Met QC Criteria

June 5, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-25PJ1046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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